Intercell has reported that interim data from a phase II clinical trial investigating the vaccine candidate for the prevention of infections with the bacterium pseudomonas aeruginosa are available. Intercell’s vaccine is a recombinant subunit vaccine consisting of two outer membrane proteins of pseudomonas aeruginosa.
In the phase II clinical trial, mechanically ventilated intensive care patients are vaccinated with Intercell’s prophylactic pseudomonas aeruginosa vaccine. These patients are at a particularly high risk of acquiring severe and often life-threatening forms of pseudomonas aeruginosa infections, such as ventilator-associated pneumonia, sepsis or soft tissue infection. Two different dosages of alum-adjuvanted vaccine and one formulation without adjuvant are used in the placebo-controlled trial.
The interim analysis from 225 out of 400 total patients to be vaccinated in this study has shown good safety and tolerability of the vaccine. In addition, robust immunogenicity by antibody induction, which were assessed by standard and avidity IgG ELISA and functional opsonization assays, could be shown.
Immune responses and safety data observed in intensive care patients appear largely comparable to results from a preceding phase I trial in healthy volunteers. Based on these interim data an independent Safety Board recommended the continuation of the study. Meanwhile, the trial is fully enrolled, having achieved recruitment of 400 patients in more than 40 intensive care units in nine countries in Europe and Latin America.
Thomas Lingelbach, COO of Intercell, said: “We are pleased with the state of the clinical conduct although the interim data are not yet decisive. Intercell’s approach to develop vaccines against the major causes of nosocomial infections has the clear potential to become the unique strategic solution for a dramatically increasing medical need.”